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Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2/PHASE3

Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)

A Phase 2/3, Multicenter, Open-Label, Non-Randomized Study to Evaluate Diagnostic Performance of GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) for Detection of Peritoneal Carcinomatosis (PC) in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)

NCT07219238•GE Healthcare

View on ClinicalTrials.gov

Summary

This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before or after institutional Standard of Care (SoC) imaging. The primary objective is to evaluate the diagnostic performance of GEH300079 (68Ga) PET/CT for the detection of PC in patients with colorectal, gastric, or ovarian primary cancers, using a composite standard of truth (SoT), in a region-based analysis. The detection of PC in patients with primary PDAC will be explored in the Phase 2 part of the study. The study is comprised of 2 distinct parts: Phase 2 aims to confirm the statistical and scientific assumptions for the Phase 3 part, and to confirm the optimal dose and timing of acquisition of GEH300079 (68Ga) PET/CT in the PC indication. Phase 2 includes 2 cohorts: Cohort A (participants with colorectal, ovarian and gastric primary cancer), and Cohort B (participants with primary PDAC), where analysis of Cohort B is descriptive only. Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET/CT for the detection of PC in patients with confirmed colorectal, gastric or ovarian primary cancers.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant is ≥18 years of age
•Participant has provided signed informed consent before any study-specific screening procedures
•Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC
•Participant has known or suspected PC from the tumor of origin. Suspicion may be based on imaging or clinical findings.
•Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment received, treatment-naïve (i.e., undergoing upfront surgery or laparoscopy) b. Completed systemic treatment (which may include neoadjuvant chemotherapy) before GEH300079 ( 68Ga) PET/CT Imaging Visit
•Participant has Eastern Cooperative Oncology Group (ECOG) performance status ≤2
•Participant is able and willing to comply with all study procedures as described in the protocol

Exclusion Criteria

•Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from screening up to 30 days after receiving the investigational medicinal product (IMP)
•Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures
•Participant needs any intervention that would delay study participation
•Participant has non-resectable extra-abdominal metastasis and/or \>3 hepatic metastases on standard work up
•Participant will not be able to complete the study, based on their anticipated life expectancy
•Participant has active bacterial, viral, or fungal infection requiring systemic antibacterial, anti-viral or antifungal therapy (topical medications are permitted)
•Participant has renal function impairment as defined by:
•1. For Phase 2: estimated glomerular filtration rate less than 60 mL/min
•2. For Phase 3: estimated glomerular filtration rate less than 30 mL/min
•Participant has severe hepatic function impairment as defined by:
+8 more criteria

Locations (2)

BAMF Health

Grand Rapids, Michigan, United States

Karolinska Universitetssjukhuset

Stockholm, Sweden

Key Dates

Start Date

March 1, 2026

Primary Completion Date

June 1, 2029

Completion Date

August 1, 2029

Last Updated

October 21, 2025

Enrollment

175

ESTIMATED participants

Conditions

Colorectal CancerGastric CancersOvarian CancersPancreatic Ductal Adenocarcinoma

Interventions

GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)

DRUG

Contacts

Michelle Straszacker

CONTACT

+44 7827 845147 michelle.straszacker@gehealthcare.com

Aimee Liu

CONTACT

617-505-2861 Aimee.Liu@gehealthcare.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)

Inclusion Criteria

Exclusion Criteria

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